NCT00941317

Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis

A Single-blind Evaluation of Device Performance and Tolerability to Nail Micro-drilling in Subjects With Onychomycosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Based on manufacturer testing, no major difference in drilling condition is expected in this study compared to the drilling conditions previously established. However clinical testing is needed to establish optimal drilling conditions to be used for further development in both unaffected and affected parts of the nail. The aim of this study is to determine the optimal drilling condition that could be used in future studies of this device in combination with topical treatment for onychomycosis.

Detailed description

This drug-free, single-blind device study will evaluate the completeness of the holes and the tolerability (pain) of the drilling process by testing several trigger levels. Subjects with distolateral onychomycosis will have a series of holes drilled into the unaffected and affected areas of 1 or 2 big toenail(s). A pain level \< 4 using the subject self-assessment Numeric Rating Scale (NRS) is considered as acceptable with regard to the study procedure. The study will use a two-cohort design in subjects with distolateral onychomycosis.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DEVICE	Pathformer (micro-drilling device)	The micro-drilling device drills the nail with a prespecified diameter drill bit and to a prespecified depth in the nail, using skin impedance (also referred to as equivalent resistivity level) as a feedback mechanism for stopping the drilling intervention at a preset trigger level value.

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-07-01
• Completion: 2009-09-01
• First posted: 2009-07-17
• Last updated: 2021-02-17

Locations

1 site across 1 country: United States